Determination of asundexian and its metabolite M-10 in human plasma by LC–MS/MS: supplementary materials

Background: The authors present a validated method for the simultaneous quantification of asundexian
(BAY 2433334) and its pharmacologically inactive major human metabolite M-10 from human plasma and
its application in clinical study sample analysis. Materials & methods: Sample preparation was performed
by protein precipitation followed by reverse phase HPLC and positive/negative ESI-MS/MS. Results: Assay
working ranges were 0.5–500 ng/ml for asundexian and 5.0–5000 ng/ml for M-10. Validation results
met the requirements of pertinent guidelines. In clinical study sample analysis, accuracy and precision
acceptance criteria for analyzed quality control samples were met and incurred sample reanalysis was
fulfilled. Conclusion: The method proved to be selective, specific, sufficiently sensitive, reproducible and
robust for the analysis of samples obtained from clinical trials.